Plain English Summary
Background and study aims
In England, the hospice movement has provided a model of good palliative (end of life) care for those with advanced progressive (worsening) disease. However, the care offered around the country can differ greatly. Older people or those with non-cancerous conditions, for instance, are less likely to receive palliative care. There are also major geographical variations in NHS provision often resulting in a mismatch between the palliative care needs of a patient/family, the resources provided to meet those needs, and patient health outcomes achieved. Casemix classifications provide the health care sector with a consistent method of classifying types of patients, their treatment and associated costs. The aim of this study is to follow participants being treated at a range of different places in order to develop a casemix classification for palliative care will enable these inequities in provision to be addressed.
Who can participate?
Adults who are receiving specialist palliative care across inpatient (hospice and hospital), community and outpatient settings, and their family carers.
What does the study involve?
Participants and their family carers are followed by the research team for up to 12 months. Patient participants and their family carers provide data on their symptoms and concerns, whether these are addressed, and other important background information. They also provide inofmration about how they previously used services. The study also includes a post-bereavement survey to family carers where appropriate, to identify symptoms and concerns immediately prior to death, and also family support needs after death. Clinicians collect data about the patient participants including background and health information, episode start and end data, case-mix variables (such as phase of illness, functional status and problem severity), alongside information on patient-level resource use in specialist palliative care settings. These data are linked to patient participant data, encrypted and transferred to the central database and analysed to understand how to better match patient-level resource use to needs.
What are the possible benefits and risks of participating?
Participants will benefit from improved matching of resources to needs at an individual level. There are no notable risks involved with participating.
Where is the study run from?
Inpatient, community and outpatient settings throughout England (UK)
When is the study starting and how long is it expected to run for?
February 2016 to May 2018
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Fliss Murtagh
fliss.murtagh@kcl.ac.uk
Trial website
http://www.kcl.ac.uk/lsm/research/divisions/cicelysaunders/research/studies/c-change/c-change.aspx
Contact information
Type
Public
Primary contact
Dr Fliss Murtagh
ORCID ID
http://orcid.org/0000-0003-1289-3726
Contact details
King’s College London
Cicely Saunders Institute
Department of Palliative Care
Policy and Rehabilitation
Faculty of Life Sciences & Medicine
Bessemer Road
London
SE5 9PJ
United Kingdom
+44 207 848 5583
fliss.murtagh@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
31205
Study information
Scientific title
C-CHANGE Workstream 4: Testing a case-mix classification in palliative care (cohort study)
Acronym
C-CHANGE
Study hypothesis
The aim of this study is to prospectively validate a case-mix classification (a system to group people into classes that are homogeneous in their resource use) for palliative care (previously developed) over time and across the range of complexity, conditions and settings.
Ethics approval
London –Bromley Research Ethics Committee, 05/09/2016, ref: 16/LO/1021
Study design
Observational; Design type: Cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
ot available in web format, please use the contact details below to request a patient information sheet
Condition
Specialty: Cancer, Primary sub-specialty: Palliative and Supportive Care; UKCRC code/ Disease: Other/ Ill-defined and unknown causes of mortality
Intervention
Patient participants will provide data on their symptoms and concerns, whether these are addressed and other key demographics and social variables. They will also provide retrospective data on their use of services. Family carers will complete data about their own circumstances including their basic demographic information, distress measured by distress thermometer, caregiver burden using the Zarit Caregiver Burden Inventory (6-item version) and questionnaires regarding the patient where the patient is too unwell to complete (e.g., SF-12v2 and Pall-CSRI). These data will be collected from patients and (separately) their main family carers using a combination of face-to-face/telephone contacts and postal questionnaires according to participants’ preferences at start, phase change, and end of episodes of care. Where phase exceeds 4 weeks, data items will be captured as for phase change.
A sample of 20-25 patients who have experienced at least two transitions of care and family carers will be purposively selected to take part in one or two face-to-face interviews. The interviews will be semi-structured and follow the interview schedule for the patient participants and family carers. Each interviews last 40 minutes, but this will be guided by the participant. In order to provide information on how transitions in care might be better negotiated to improve outcomes and experiences, the interviews will cover these key topics; communication, coordination of care, information and support needs, discharge planning, and experience of transitions. Data from the first five interviews will be analysed and feedback from our Patient and Public Involvement group will be used to refine the interview schedule for subsequent interviews.
Participants and their family carers will be followed to test a case-mix classification longitudinally through transitions between settings (e.g. from home to hospital, from hospice to home etc.). The study will also include a post bereavement survey to family carers where appropriate, to identify symptoms and concerns immediately prior to death, and also family support needs after death.
Clinicians will collect data about the patient participants on demographic and clinical data, episode start and end data, potential case-mix variables (e.g., phase of illness, functional status and problem severity) alongside information on patient-level resource use in specialist palliative care settings. These data will be linked to patient participant data, encrypted and transferred to the central database and analysed to understand how we can better match patient-level resource use to needs.
Intervention type
Other
Phase
Drug names
Primary outcome measures
Cost of the episode of care (and cost per phase and per diem) is captured by i) staff activity matrix at every contact, the Palliative care Resource Use Score (PRUS) at change of phase of illness and at the end of episode, and patient/carer completed inventory of palliative care services received based on the Client Services Receipt Inventory (Pall-CSRI) at end of episodes of care or three monthly whichever is earlier over the telephone.
Secondary outcome measures
No secondary outcome measures.
Overall trial start date
01/02/2016
Overall trial end date
31/05/2018
Reason abandoned
Eligibility
Participant inclusion criteria
1. All adult patients (≥18 years) receiving specialist palliative care
2. People with advanced disease, regardless of primary diagnosis
3. Across inpatient (hospice and hospital), community and outpatient settings
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 300; UK Sample Size: 300
Participant exclusion criteria
1. Patients considered by clinicians too ill to be approached
2. Not receiving specialist palliative care
3. Aged under 18 years
Recruitment start date
01/11/2016
Recruitment end date
28/02/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
King’s College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
Trial participating centre
Princess Royal University Hospital
Farnborough Common
Orpington
BR6 8ND
United Kingdom
Trial participating centre
St Christopher’s Hospice
51-59 Lawrie Park Road
London
SE26 6DZ
United Kingdom
Trial participating centre
St Joseph’s Hospice
Mare Street
London
E8 4SA
United Kingdom
Trial participating centre
Royal Sussex County Hosptial
Eastern Road
Brighton
BN2 5BE
United Kingdom
Trial participating centre
Brighton General Hosptial
Elm Grove
Brighton
BN2 3EW
United Kingdom
Trial participating centre
Martlets Hospice
Wayfield Avenue
Hove
BN3 7LW
United Kingdom
Trial participating centre
Forest Holmes Hospice
Longfleet Road
Poole
BH15 2JB
United Kingdom
Trial participating centre
St Catherine’s Hospice
Throxenby Lane
Scarborough
YO12 5RE
United Kingdom
Trial participating centre
St Giles Hospice
Fisherwick Road
Whittington
WS14 9LH
United Kingdom
Trial participating centre
St Luke’s Hospice
Little Common Lane
Sheffield
S11 9NE
United Kingdom
Sponsor information
Organisation
King's College London
Sponsor details
Room 1.8 Hodgkin Building
Guy’s Campus
London
SE1 4UL
United Kingdom
+44 20 7848 6960
Keith.brennan@kcl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publications in a high-impact peer reviewed journal. Dissemination to participating sites through workshops and feedback meetings, and at regional, national and international conferences.
IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Fliss Murtagh (fliss.murtagh@kcl.ac.uk)
Intention to publish date
31/12/2018
Participant level data
Available on request
Results - basic reporting
Publication summary